(170 days)
The RadiForce MX270W is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device is not for use for screening or diagnostic mammography.
The RadiForce MX270W is a color LCD monitor for viewing medical images other than those of mammography. The matrix size (or resolution) of the panel is 2560 x 1440 pixels (3.7MP) with a pixel pitch of 0.233 mm.
Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used.
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including MX270W based on several QC guidelines. The RadiCS and its subset, RadiCS LE are included in this 510(k) submission as an accessory to the RadiForce MX270W.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the EIZO RadiForce MX270W monitor.
Note: The provided document is a 510(k) summary for a medical display monitor. As such, the "device" in question is the monitor itself, and the "acceptance criteria" relate to its technical performance for displaying medical images, not a diagnostic AI algorithm. Consequently, many of the requested data points related to AI models (like sample sizes for test/training sets, ground truth establishment for AI, MRMC studies, standalone AI performance) are not applicable to this type of medical device submission.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (RadiForce MX270W) |
|---|---|---|
| Resolution/Matrix Size | Equivalent to or better than predicate device (1600x1200) | 2560 x 1440 pixels (3.7MP) |
| Pixel Pitch/Size | Equivalent to or better than predicate device (0.270 x 0.270 mm) | 0.233 x 0.233 mm |
| DICOM Calibrated Luminance | Equivalent to or better than predicate device (150 cd/m2) | 170 cd/m2 |
| Maximum Luminance | Equivalent to predicate device (300 cd/m2) | 300 cd/m2 |
| Backlight Technology | No adverse effects on image quality from new technology | LED backlight (no adverse effects recognized) |
| Tone Curve Conformance | DICOM GSDF compliance | DICOM GSDF compliant |
| Video Interface | Equivalent or improved digital interface technology | Digital interfaces (DVI, DisplayPort only) |
| QC Software | Same as predicate device (for maintenance) | RadiCS / RadiCS LE |
| Backlight Stability | Equipped with Backlight Sensor (BS) | Equipped with BS |
| Grayscale Calibration | Accurate automatic or external calibration | Built-in Front Sensor (IFS) for automatic calibration, comparable accuracy to external sensors advertised. |
| DICOM GSDF Conformance | Conforms to AAPM TG18 guideline | Verification of conformance |
| Luminance Non-uniformity | Meets TG18 guideline specifications | Measurement taken, implicitly meets criteria |
| Chromaticity Non-uniformity | Meets TG18 guideline specifications | Measurement taken, implicitly meets criteria |
| Chromaticity at Center | Meets FDA guidance for FFDMM systems | Measurement taken, implicitly meets criteria |
| Artifact Presence | Absence of miscellaneous artifacts | Visual check of presence/absence |
| Pixel Defects/Faults | Within manufacturer's agreed limits | Meets agreed maximum numbers |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of an AI algorithm's test set. The "test set" here refers to individual monitors or a representative sample of monitors undergoing a series of bench tests. The document does not specify the number of monitors tested, but it implies standard manufacturing quality assurance and testing procedures.
- Data Provenance: The tests were conducted by the manufacturer, EIZO NANAO Corporation, in Japan, prior to the 510(k) submission. This is retrospective data from internal testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This submission is for a display monitor, not an AI diagnostic algorithm. Ground truth, in the context of AI, usually refers to definitive diagnoses by experts or pathology. For a monitor, the "ground truth" and acceptance criteria are based on established technical standards and guidelines (like DICOM GSDF, AAPM TG18, FDA guidance for FFDMM systems) that define acceptable display performance. No individual medical expert "established" ground truth in this context; instead, the criteria are defined by industry and regulatory bodies.
4. Adjudication Method for the Test Set
- Not applicable. Since there's no "ground truth" in the AI sense established by multiple experts requiring adjudication, there is no adjudication method used. The tests are quantitative and objective measurements against predefined technical specifications.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI algorithms on human reader performance in diagnostic tasks. This submission is for a display monitor, which is a tool for viewing images, not an AI algorithm that assists in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone AI algorithm performance study was not done. This device is a monitor, not an AI algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Technical Standards and Guidelines: The "ground truth" for evaluating the RadiForce MX270W's performance is adherence to established technical specifications and industry standards for medical displays. These include:
- DICOM GSDF (Digital Imaging and Communications in Medicine Grayscale Standard Display Function)
- AAPM Task Group 18 (TG18) guidelines for "Assessment of Display Performance for Medical Imaging Systems"
- FDA Guidance for Industry and FDA Staff: "Display Accessories for Full-Field Digital Mammography Systems - Premarket Notification (510(k)) Submissions" (specifically for chromaticity measurement).
- Manufacturer's internal specifications and agreements with LCD panel suppliers for pixel defects.
8. The Sample Size for the Training Set
- Not applicable. This device is a monitor, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, no training set for an AI algorithm is involved.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).